Reactice Reactivating Ice Baume

Reactice Reactivating Ice Baume
SPL v3
SPL
SPL Set ID 9d9cf361-49ce-4b0d-a061-24330d319170
Route
TOPICAL
Published
Effective Date 2012-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (118.29 mL)
Inactive Ingredients
Dimethyl Sulfone Clove Peppermint Oil Eucalyptus Oil Aloe Vera Leaf Ascorbic Acid Tocopherol Glycine Jojoba Oil Arnica Montana Flower C13-14 Isoparaffin Laureth-7 Sodium Hydroxymethylglycinate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-07-21

Description

Active ingredients              Purpose Menthol (5%)                   External Analgesic        


Medication Information

Warnings and Precautions

For External use only. When using this product avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing,seek the advice of your doctor before using this product.

Indications and Usage

Consult a doctor and discontinue use if conditions worsen or persist for more than 7 days.

Dosage and Administration

Directions for use



Apply cream to sore muscles and joints and massage into skin as needed. For adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Description

Active ingredients              Purpose Menthol (5%)                   External Analgesic        

Section 50565-1

Keep out of reach of children

Section 51727-6

Water, Dimethyl Sulfone, Clove bud oil, Peppermint oil, Eucalyptus oil, Aloe Vera, Ascorbic acid, Tocopherol, Glycine, Wintergreen oil, Jojoba oil, Arnica Montana  Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.















Section 51945-4

Reactice

Reactivating Ice Baume

external analgesic

16 fl oz./473ml















Section 55105-1

Uses

For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises, strains, bruises,  and sprains

Section 55106-9

Active ingredients              Purpose

Menthol (5%)                   External Analgesic        


Structured Label Content

Indications and Usage (34067-9)

Consult a doctor and discontinue use if conditions worsen or persist for more than 7 days.

Dosage and Administration (34068-7)

Directions for use



Apply cream to sore muscles and joints and massage into skin as needed. For adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Warnings and Precautions (34071-1)

For External use only. When using this product avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing,seek the advice of your doctor before using this product.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Water, Dimethyl Sulfone, Clove bud oil, Peppermint oil, Eucalyptus oil, Aloe Vera, Ascorbic acid, Tocopherol, Glycine, Wintergreen oil, Jojoba oil, Arnica Montana  Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.















Section 51945-4 (51945-4)

Reactice

Reactivating Ice Baume

external analgesic

16 fl oz./473ml















Section 55105-1 (55105-1)

Uses

For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises, strains, bruises,  and sprains

Section 55106-9 (55106-9)

Active ingredients              Purpose

Menthol (5%)                   External Analgesic        


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)